From Tradition to Evidence-base: Leveraging TCM Human Use Experience in Modern Drug Development

Introduction: Traditional Chinese medicines (TCM) have been used in China for hundreds, and in some cases, thousands of years, accumulating substantial clinical experience known as ''TCM Human Use Experience.'' These medicines are also widely used in modern medical institutions, presenting the challenge of leveraging this extensive experience and applying modern evidence-based medicine and pharmaceutical methods for the scientific research and development of new drugs from ethnic medicines. Methods: A literature and regulatory search was conducted using PubMed, Web of Science, CNKI, and relevant national databases (CDE, FDA, PMDA, EMA) to collect peer-reviewed studies and policies on TCM human use experience and its integration into modern drug development. In total, 112 articles and regulations were reviewed, with 12 excluded due to irrelevance to empirical TCM applications. Results: Our review identifies the methodological challenges and innovations necessary for integrating TCM into the modern medical landscape. We propose a systematic approach for the collection and analysis of TCM clinical data, including the establishment of a standardized database for TCM human use experience, the translation of TCM concepts into modern medical practices, and ensuring efficacy, safety, and regulatory compliance through rigorous data methodologies. Discussion: Our findings advocate for a balanced approach that respects the rich heritage of TCM while embracing contemporary scientific and clinical standards. This integration has the potential to enrich global healthcare with diverse, evidence-based treatment options, significantly contributing to the broader acceptance and integration of TCM into global healthcare systems.